MEDICATION GUIDE Brexpiprazole (breks PIP ray zole) Tablets

What is the most important information I should know about brexpiprazole tablets? Brexpiprazole tablets may cause serious side effects, including:Increased risk of death in elderly people with dementia-related psychosis. Medicines like brexpiprazole tablets can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). Brexpiprazole tablets are not approved for the treatment of people with dementia-related psychosis.Increased risk of suicidal thoughts and actions. Antidepressant medicines may increase suicidal thoughts and actions in some children, adolescents, and young adults especially within the first few months of treatment or when the dose is changed. Depression and other mental illnesses are the most important causes of suicidal thoughts and actions. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member? Pay close attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings. This is very important when brexpiprazole tablets or the antidepressant medicine is started or when the dose is changed.Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions.Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms.Call a healthcare provider right away if you or your family member have any of the following symptoms, especially if they are new, worse, or worry you: o thoughts about suicide or dying o attempts to commit suicide o new or worsening depression o new or worsening anxiety o feeling very agitated or restless o panic attacks o trouble sleeping (insomnia) o new or worsening irritability o acting aggressive, being angry, or violent o acting on dangerous impulses o an extreme increase in activity or talking (mania) o other unusual changes in behavior or mood

What are brexpiprazole tablets? Brexpiprazole tablets are prescription medicine used: with other antidepressant medicines to treat major depressive disorder (MDD) in adults.to treat schizophrenia in adults It is not known if brexpiprazole tablets are safe and effective in children with MDD. It is not known if brexpiprazole tablets are safe and effective in children under 13 years of age with schizophrenia. Do not take brexpiprazole tablets if you are allergic to brexpiprazole or any of the ingredients in brexpiprazole tablets. See the end of this Medication Guide for a complete list of ingredients in brexpiprazole tablets.

Before taking brexpiprazole tablets, tell your healthcare provider about all of your medical conditions, including if you:have or have had heart problems or a stroke have or have had low or high blood pressurehave or have had diabetes or high blood sugar or a family history of diabetes or high blood sugar. Your healthcare provider should check your blood sugar before you start brexpiprazole tablets and during treatment with brexpiprazole tablets.have or have had high levels of total cholesterol, LDL cholesterol, or triglycerides, or low levels of HDL cholesterol have or have had seizures (convulsions)have or have had kidney or liver problemshave or have had a low white blood cell countare pregnant or plan to become pregnant. Brexpiprazole tablets may harm your unborn baby. Taking brexpiprazole tablets during your third trimester of pregnancy may cause your baby to have abnormal muscle movements or withdrawal symptoms after birth. Tell your healthcare provider if you become pregnant or think you are pregnant during treatment with brexpiprazole tablets.If you become pregnant during treatment with brexpiprazole tablets, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/.are breastfeeding or plan to breastfeed. It is not known if brexpiprazole passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with brexpiprazole tablets.Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Brexpiprazole tablets and other medicines may affect each other causing possible serious side effects. Brexpiprazole tablets may affect the way other medicines work, and other medicines may affect how brexpiprazole tablets works. Your healthcare provider can tell you if it is safe to take brexpiprazole tablets with your other medicines. Do not start or stop any medicines during treatment with brexpiprazole tablets without first talking to your healthcare provider. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I take brexpiprazole tablets? Take brexpiprazole tablets exactly as your healthcare provider tells you to take it. Your healthcare provider may change your dose if needed. Do not change the dose or stop taking brexpiprazole tablets without first talking to your healthcare provider.Take brexpiprazole tablets 1 time each day with or without food.If you take too much brexpiprazole tablets, call your healthcare provider or a certified Poison Control Center at 1-800-222-1222 or go to www.poison.org, or go to the nearest hospital emergency room right away.

What should I avoid while taking brexpiprazole tablets? Do not drive a car, operate machinery, or do other dangerous activities until you know how brexpiprazole tablets affects you. Brexpiprazole tablets may make you feel drowsy.Do not become too hot or dehydrated during treatment with brexpiprazole tablets Do not exercise too much.In hot weather, stay inside in a cool place if possible.Stay out of the sun. Do not wear too much clothing or heavy clothing. Drink plenty of water

What are the possible side effects of brexpiprazole tablets? Brexpiprazole tablets may cause serious side effects, including: See “What is the most important information I should know about brexpiprazole tablets?” Stroke (cerebrovascular problems) in elderly people with dementia-related psychosis that can lead to death.Neuroleptic Malignant Syndrome (NMS) is a serious condition that can lead to death: Call your healthcare provider or go to the nearest hospital emergency room right away if you have some or all of the following signs and symptoms of NMS: high feverchanges in your breathing, heart rate, and blood pressure. stiff musclesconfusion increased sweatingUncontrolled body movements (tardive dyskinesia): Brexpiprazole tablets may cause movements that you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even if you stop taking brexpiprazole tablets. Tardive dyskinesia may also start after you stop taking brexpiprazole tablets.Problems with your metabolism such as:high blood sugar (hyperglycemia) and diabetes. Increases in blood sugar can happen in some people who take brexpiprazole tablets. Extremely high blood sugar can lead to coma or death. Your healthcare provider should check your blood sugar before you start, or soon after you start brexpiprazole tablets and then regularly during long term treatment with brexpiprazole tablets.Call your healthcare provider if you have any of these symptoms of high blood sugar during treatment with brexpiprazole tablets: feel very thirsty feel very hungryfeel sick to your stomachfeel weak or tiredneed to urinate more than usual feel confused, or your breath smells fruityincreased fat levels (cholesterol and triglycerides) in your blood. Your healthcare provider should check the fat levels in your blood before you start, or soon after you start brexpiprazole tablets, and then periodically during treatment with brexpiprazole tablets.weight gain. You and your healthcare provider should check your weight before you start and often during treatment with brexpiprazole tablets.Unusual and uncontrollable (compulsive) urges. Some people taking brexpiprazole tablets have had strong unusual urges, to gamble and gambling that cannot be controlled (compulsive gambling). Other compulsive urges include sexual urges, shopping, and eating or binge eating. If you or your family members notice that you are having unusual strong urges, talk to your healthcare provider.Low white blood cell count. Your healthcare provider may do blood tests during the first few months of treatment with brexpiprazole tablets.Decreased blood pressure (orthostatic hypotension). You may feel lightheaded or faint when you rise too quickly from a sitting or lying position.Falls. Brexpiprazole tablets may make you sleepy or dizzy, may cause a decrease in your blood pressure when changing position (orthostatic hypotension), and can slow your thinking and motor skills which may lead to falls that can cause fractures or other injuries. Seizures (convulsions)Problems controlling your body temperature so that you feel too warm. See “What should I avoid while taking brexpiprazole tablets?”Difficulty swallowing that can cause food or liquid to get into your lungsSleepiness, drowsiness, feeling tired, difficulty thinking and doing normal activities. See “What should I avoid while taking brexpiprazole tablets?”The most common side effects of brexpiprazole tablets include weight gain and restlessness or feeling like you need to move (akathisia). These are not all the possible side effects of brexpiprazole tablets. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store brexpiprazole tablets? Store brexpiprazole tablets at room temperature, between 68°F to 77°F (20°C to 25°C). Keep brexpiprazole tablets and all medicines out of the reach of children.

General information about the safe and effective use of brexpiprazole tablets. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use brexpiprazole tablets for a condition for which it was not prescribed. Do not give brexpiprazole tablets to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about brexpiprazole tablets that is written for healthcare professionals.

What are the ingredients in brexpiprazole tablets? Active ingredient: brexpiprazole Inactive ingredients: microcrystalline cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose, hydroxypropyl cellulose, magnesium stearate, hypromellose, talc, propylene glycol, polyethylene glycol. Colorants includes titanium dioxide, iron oxide red (0.25 mg and 3 mg), FD&C Yellow #6 (0.5 mg), iron oxide yellow (1 mg, 2 mg and 3 mg), FD&C Blue #2 (2 mg). Pediatric use information is approved for Otsuka Pharmaceutical Company, Ltd.’s Rexulti^® (brexpiprazole) tablets. However, due to Otsuka Pharmaceutical Company, LTD.’s marketing exclusivity rights, this drug product is not labeled with that information. Marketed by: Ajanta Pharma USA Inc. Bridgewater, NJ 08807. Made in INDIA. #All trademarks are the properties of their respective owners